The tabs that appear in the navigation bar depend on your account permissions and your Vault’s custom configuration.
Note: Depending on your Admin’s configuration, your Vault’s object, field, and section labels, lifecycle states, and workflows may differ from the general information in all articles. Refer to your organization’s business processes for guidance.
For information on navigation items in all Safety Suite Vaults, see Navigate Safety Suite.
Inbox
Use the Inbox tab to perform intake. The Inbox organizes Inbox Items into a detailed table on an object record list page, providing at-a-glance key information. You can sort Inbox Items in ascending or descending order using any column in the table, such as New Info Date, Product, Organization, Seriousness, Due Date, and more.
Cases
Use the Cases tab to access all Cases in your Vault. To create a Case, you must create an Inbox Item from the Inbox tab and then promote it to a Case. You cannot create a Case directly from the Cases tab.
Localized Cases
Use the Localized Cases tab to access all Localized Cases in your Vault.
Transmissions
Use the Transmissions tab to manage Submissions. Safety supports both manual and automated submissions of Individual Case Safety Reports (ICSRs) to the FDA.
If you do not see the Transmissions tab, you may not have permission to participate in Submission workflows. By default, only users assigned the Head of Safety and Distribution Manager roles can participate in Submissions.
Case Collections
Use the Case Collections tab to review groups of Case Numbers collected for the purpose of non-submission reporting (for example, reporting to an auditor or ethics committee about a specific subset of Cases). You can generate Safety Report Document Collections from this tab, allowing you to export multiple ICH E2B(R3) or CIOMS I forms at once. After generating safety reports, a link to the associated binder appears on the Case Collection, which allows for easy downloading and sharing of safety reports with partners or relevant health authorities.